Tag: IEC 62304

Updated almost 2 years ago 1 comment

Doing a Software Release in Compliance With IEC 62304

Dr. Oliver Eidel

Software System Testing Based on the IEC 62304

Dr. Oliver Eidel

Medical Device Software Architecture Documentation (IEC 62304)

Dr. Oliver Eidel

Software Verification For Medical Device Software (IEC 62304)

Dr. Oliver Eidel

Writing Software Requirements Based on the IEC 62304

Dr. Oliver Eidel

Updated 12 days ago 2 comments

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance

Dr. Oliver Eidel

IEC 62304 Walkthrough

Dr. Oliver Eidel

Questions

Can We Document Our Software After We've Developed It?

We want to certify our software as a medical device, but we've already developed parts of it (or all of it). Do we have to re-do our entire development, creating "compliant" documentation along the wa

about 2 years ago

Don't worry, young Padawan. You can document your software after you've developed it. This works for your first software version, i.e. the first medi

Should You Automate Your Software Architecture Documentation?

For our software architecture documentation, we’re planning to have some high-level system diagrams. Drawing these manually seems inefficient, and we fear that they’ll be outdated soon when we continu

No. Do it manually. Long AnswerYour software architecture diagram should be on a rather high level (see the example here). It’ll be really hard to aut

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?

We’re currently using SaaS tools like GitHub to host our code. Our consultant told us that that’s not okay and we need to self-host everything. His reason was that we’re only allowed to use tools whic

Your consultant is wrong. You can use GitHub. And look for another consultant. Long AnswerThe ISO 13485 requires you to “validate” all quality-relevan

Do We Have to Re-Do All Software System Tests After a Minor Change?

We’ve certified and released the first version of our software as a medical device. Now we’re working on a minor update which just fixes some bugs. Do we have to re-do all our software system tests be

No, not necessarily. Only re-do the tests for software requirements which were touched by the (code) change. But be sure to document your reasoning. L

Do Auditors Read Your Code?

We’re wondering whether our auditor will read the source code of our software. Does that mean we have to choose a programming language which many people know, like Python?

No, your auditor won’t read your code. Long AnswerThink about it this way: The probability of your auditor being a software developer is low (yes, I w

How to document SOUP for IEC 62304 compliance?

Our python backend contains lots of dependencies, for example flask and the requests library. According to the IEC 62304, third-party dependencies are “SOUP” and must be documented. We have no idea ho